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EANM position paper on article 56 of the Council Directive 2013/59/Euratom (basic safety standards) for nuclear medicine therapy.

  • Konijnenberg, Mark1
  • Herrmann, Ken2
  • Kobe, Carsten3
  • Verburg, Frederik1
  • Hindorf, Cecilia4
  • Hustinx, Roland5
  • Lassmann, Michael6
  • 1 Department of Radiology and Nuclear Medicine, Erasmus MC, Rotterdam, Netherlands. , (Netherlands)
  • 2 Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK), University Hospital Essen, Essen, Germany. , (Germany)
  • 3 Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. , (Germany)
  • 4 Department of Nuclear Medicine Physics, Skåne University Hospital, Lund, Sweden. , (Sweden)
  • 5 Service de Médecine Nucléaire et d'Imagerie Oncologique, Département de Physique médicale, Université de Liège - GIGA-CRC in vivo imaging, Centre Hospitalier Universitaire de Liège, Liège, Belgium. , (Belgium)
  • 6 Department of Nuclear Medicine, Universitätsklinikum Würzburg, Klinik und Poliklinik für Nuklearmedizin, Oberdürrbacher Str. 6, 97080, Würzburg, Germany. [email protected] , (Germany)
Published Article
European Journal of Nuclear Medicine
Publication Date
Oct 15, 2020
DOI: 10.1007/s00259-020-05038-9
PMID: 33057773


The EC Directive 2013/59/Euratom states in article 56 that exposures of target volumes in nuclear medicine treatments shall be individually planned and their delivery appropriately verified. The Directive also mentions that medical physics experts should always be appropriately involved in those treatments. Although it is obvious that, in nuclear medicine practice, every nuclear medicine physician and physicist should follow national rules and legislation, the EANM considered it necessary to provide guidance on how to interpret the Directive statements for nuclear medicine treatments.For this purpose, the EANM proposes to distinguish three levels in compliance to the optimization principle in the directive, inspired by the indication of levels in prescribing, recording and reporting of absorbed doses after radiotherapy defined by the International Commission on Radiation Units and Measurements (ICRU): Most nuclear medicine treatments currently applied in Europe are standardized. The minimum requirement for those treatments is ICRU level 1 ("activity-based prescription and patient-averaged dosimetry"), which is defined by administering the activity within 10% of the intended activity, typically according to the package insert or to the respective EANM guidelines, followed by verification of the therapy delivery, if applicable. Non-standardized treatments are essentially those in developmental phase or approved radiopharmaceuticals being used off-label with significantly (> 25% more than in the label) higher activities. These treatments should comply with ICRU level 2 ("activity-based prescription and patient-specific dosimetry"), which implies recording and reporting of the absorbed dose to organs at risk and optionally the absorbed dose to treatment regions. The EANM strongly encourages to foster research that eventually leads to treatment planning according to ICRU level 3 ("dosimetry-guided patient-specific prescription and verification"), whenever possible and relevant. Evidence for superiority of therapy prescription on basis of patient-specific dosimetry has not been obtained. However, the authors believe that a better understanding of therapy dosimetry, i.e. how much and where the energy is delivered, and radiobiology, i.e. radiation-related processes in tissues, are keys to the long-term improvement of our treatments.

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